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Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304577
First Posted: March 20, 2006
Last Update Posted: March 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Erasmus Medical Center
  Purpose
Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized prospective study.

Condition Intervention Phase
Strabismus Procedure: Bilateral recession Procedure: Unilateral recession and resection Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Study Start Date: January 1998
Estimated Study Completion Date: December 2001
Detailed Description:
We randomly assigned 124 patients (average age 5.8) from twelve participating clinics in Germany and the Netherlands to either BR or RR. Patients did not have demonstrable binocular vision at baseline. The angle of strabismus was measured pre- and postoperatively in a standardized fashion. The primary parameter to assess difference between BR and RR was the variation of the latent angle of strabismus at distance at three months postoperatively, secondary outcomes were reduction of convergence excess and binocular vision.
  Eligibility

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible were all children aged three to eight years with a normal psychophysical development, and onset of esotropia before age one who visited one of the clinics during the study period.

Exclusion Criteria:

  • previous strabismus surgery, an angle of strabismus larger than 24° or smaller than 10°, any normal binocular vision, convergence excess with angle of strabismus at near fixation 1.5 times larger than the angle at distance, more than 1 line Logmar acuity difference between the two eyes, hypermetropia over 6 diopters or myopia over 3 diopters, up- or downshoot in (25°) adduction more than 8°, V-pattern (25° up and down gaze) over 8°, A-pattern (25° up and down gaze) over 5° and manifest vertical strabismus over 4°
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304577


Locations
Germany
Dept. Ophthalmology
Bonn, Germany
Dept. Ophthalmology
Erlangen, Germany
Dept. Ophthalmology
Essen, Germany
Dept. Ophthalmology
Frankfurt, Germany
Dept. Ophthalmology
Freiburg, Germany
Dept. Ophthalmology
Hamburg, Germany
Dept. Ophthalmology
Heidelberg, Germany
Dept. Ophthalmology
Regensburg, Germany
Dept. Ophthalmology
Tuebingen, Germany
Netherlands
Dept. Ophthalmology
Maastricht, Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Dept. Ophthalmology
Utrecht, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Study Chair: Huib J. Simonsz, MD, PhD Erasmus MC, Rotterdam
  More Information

ClinicalTrials.gov Identifier: NCT00304577     History of Changes
Other Study ID Numbers: 662720
First Submitted: March 17, 2006
First Posted: March 20, 2006
Last Update Posted: March 20, 2006
Last Verified: September 2005

Keywords provided by Erasmus Medical Center:
Strabismus
Esotropia
Surgical techniques

Additional relevant MeSH terms:
Strabismus
Esotropia
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases